They will be required to support GMP operations within the LDM facility. The job ... â¢High Technical ability and confi
Job Description Job Title : Job Id : Target Openings : Locations :
Sterile Dosage Forms Production Lead - Sandwich 1011257 1 United Kingdom-Sandwich
Organizational Marketing Statement Pfizer Inc: Working together for a healthier world Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. Role Description The Sterile Dosage Forms Production Lead will have a proven track record of working within a GMP Sterile manufacturing facility and be able to demonstrate a significant level of expertise in this field. They will be required to support GMP operations within the LDM facility. The job holder would report into the Liquid Dose Production Manager and would be expected to deputise for them, therefore it would beneficial that they have some line management experience. An exciting opportunity exists for a highly motivated self-starter to join the Liquid Dose Manufacturing group at Pfizer Sandwich. This will be an opportunity to work within a dynamic environment and with a team supporting the development and clinical manufacturing of a wide range of products. The Sterile Dosage Forms Production Lead - will have a proven track record of working within a GMP Sterile manufacturing facility and be able to demonstrate a significant level of expertise in this field. The job holder will report into the Liquid Dose Production Manager and would be expected to deputise for them, therefore it would beneficial that they have some line management experience. Responsibilities •Operate proficiently a wide range of manufacturing equipment to manufacture development and clinical trial materials in GMP areas following procedures and guidelines. •Accurate evaluation of GMP documents with the associated management of any issues or trends
•Generation of batch records and associated GMP documentation and accurate completion of working batch records and all associated GMP documentation to a high standard •Broad understanding of good cGMP documentation practices and ability to apply knowledge to all documents related to sterile Product manufacture leading peer reviews and RFT targets. •Generate training material, Risk, COSHH Assessments, SOPs where required. Lead internal and external compliance inspections. •Exhibits broad working competence level for all core manufacturing tasks and demonstrates a broad range of operational knowledge of sterile processing equipment. Has knowledge and ability to operate more complex processes, competently train trainers and coaches others within the facility. •Demonstrates maturity and a positive attitude in assisting and training members of the team, offering advice, coaching, and mentoring. Reviews work and documentation of trainees for accuracy. Provides feedback to Production manager on performance and progression. •High Technical ability and confidence to identify, communicate, escalate and wherever possible, resolve issues seen during processing and provide manufacturing support to Technicians within the LDM. •Provide supervisory support to the manufacturing team in the absence of area manager. •As a subject matter expert on sterile process trains contributes to pre-manufacturing risk assessments and technical transfers. Ability to solve complex technical problems across a range of processes and delivers risk assessed options to resolution. •Supports in the validation, qualification and commissioning requirements for equipment and utilities used in cGMP operations as a technical and operational subject matter expert. •Has developed ability to lead others through change, acts as a change sponsor for new initiatives and changing work requirements. Demonstrated ability to make decisions, takes action, and directs others. •Leads others with a positive, "can-do" attitude, for an engaged, forward looking workforce. •Operate proficiently a wide range of manufacturing equipment to manufacture development and clinical trial materials in GMP areas following procedures and guidelines. •Accurate evaluation of GMP documents with the associated management of any issues or trends •Generation of batch records and associated GMP documentation and accurate completion of working batch records and all associated GMP documentation to a high standard •Exhibits broad working competence level for all core manufacturing tasks and demonstrates a broad range of operational knowledge of sterile processing equipment. Has knowledge and ability to operate more complex processes, competently train trainers and coaches others within the facility. •High Technical ability and confidence to identify, communicate, escalate and wherever possible, resolve issues seen during processing and provide manufacturing support to Technicians within the LDM. •As a subject matter expert on sterile process trains contributes to pre-manufacturing risk assessments and technical transfers. Ability to solve complex technical problems across a range of processes and delivers risk assessed options to resolution.
Qualifications •Educated to degree level in pharmaceutical sciences or related life science. Experience in an equivalent role may also be considered with supporting relevant qualifications. •Comprehensive knowledge of the development and manufacture of sterile dosage forms within a GMP environment is essential. •Experience of sterile product manufacturing equipment, equipment qualification, computer control systems. •Comprehensive knowledge of sterilization processes and associated equipment. •Knowledge of GMP and management of quality through quality systems is expected. •Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team matrix working. Needs to have proven ability to deliver technical reports and presentations. •Experience of managing and leading a small team within a manufacturing environment would be advantageous. •Interprets internal / external business challenges and best practices to recommend improvements and innovative solutions to processes and services. QUALIFICATIONS/ EXPERIENCE/ SKILLS/ KNOWLEDGE: •Comprehensive knowledge of the development and manufacture of sterile dosage forms within a GMP environment is essential. •Experience of sterile product manufacturing equipment, equipment qualification, computer control systems. •Comprehensive knowledge of sterilization processes and associated equipment. •Knowledge of GMP and management of quality through quality systems is expected. •Experience of managing and leading a small team within a manufacturing environment would be advantageous. EDUCATIONAL BACKGROUND: •Educated to degree level in pharmaceutical sciences or related life science UNIQUE SELLING POINTS: •Opportunity to work in a facility with a wide range of manufacturing capabilities and liquid dose equipment •Opportunity to support a diverse product portfolio and supply of important new drugs for clinical trials. •Key role within the group, individual will need to be aware of the importance of their work and how it will significantly reflect the performance of the Liquid dose manufacturing facility. Equal Employment Opportunity Pfizer's aim is to provide equality of opportunity in the recruitment process by avoiding discrimination on the grounds of: age, disability, gender reassignment, race, religion or belief, sex, sexual orientation, marriage & civil partnership, pregnancy & maternity, political persuasion
or trade union membership. At Pfizer we are creating an organisation and promoting a culture that respects each individual's unique character and life experiences, and reflects the diversity of our customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported, thus enabling superior business results.
